Effect of Leg and Heel Massage on Pain During Heel Blood Collection Newborns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baby Foot and Leg Massage.
- Who it may be relevant to
- Registry conditions: Pain, Infant ALL. Basic parameters: 1 Day — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Leg and Heel Massage on Pain Experienced During Heel Blood Collection and Physiological Parameters in Newborns: Randomized Controlled Study
Overview
This study was planned to evaluate the effect of leg and heel massage on newborns, the pain experienced during heel blood collection, and the effects on physiological parameters. H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group. H2: Heart rates are lower in leg and heel massage group than control group. H3: Oxygen saturation levels are higher in leg and heel massage group than control group.
Detailed description
In this study, there will be two groups as the intervention (who will receive leg and heel massage) and the control group (who will receive routine care). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 30 cases in each group would be sufficient for 80% power. Infants who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The heel blood collection will be applied to both the intervention and control groups. For children in the massage group, the massage will be applied to both legs and heels of the baby. Immediately before the procedure, each leg and heel will be massaged for three minutes. The control group will receive heel blood collection with routine care. A researcher and a nurse were employed for the heel blood collection both for the intervention and control groups. A pediatric nurse performed the heel blood collection for all infants and the other researcher helped the children to assess their pain, heart rates and Oxygen saturation. Measurements 5 minutes before the heel prick procedure, during the procedure (1st minute) and 5 minutes after the heel prick application. The heel blood collection will be performed by the same nurse both in the intervention and control groups.
Interventions
- Other Baby Foot and Leg Massage
Baby Foot Massage stages * The baby is placed on his back, either on the bed or on the couch. * One of the baby's feet is lifted into the air by grasping the back of the ankle. * Start stroking with circular movements, starting from the heel and moving up to the toes. Stroking should be done with the thumb. * Here, it might be good to get between the toes. * The same procedure is applied to the other foot. * Massage is continued until it is noticed that the baby calms down. Baby Leg Massage st
Primary outcome measures
- Difference of the mean score of the "Newborn Infants Pain Scale" between intervention and control groups [Time frame: 9 months]
Secondary outcome measures (2)
- Difference of the mean score of the heart rate peak between intervention and control groups [Time frame: 9 months]
- Difference of the mean score of the oxygen saturation between intervention and control groups [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- Gestational age is 38-41 weeks,
- The birth weight of the newborn is >2500 g
- Vital signs should be stable before the procedure,
- Postanatal age is between 2-28 days,
- There are no contraindications for the application of massage
- Delivery of the newborn to the mother after birth
- Permission of the parents of the newborn participating in the research
- Fasting period less than 3 hours/fed 30 minutes before
- A newborn who does not cry before heel blood is taken
Exclusion criteria
- Newborns who need respiratory support,
- Newborns with any neurological disorders (seizures)
- Newborns using opioids or babies born to mothers using opioids
- Newborns taking muscle relaxants, sedatives, analgesics
- Babies with major congenital anomalies
- Babies with an APGAR score of less than 7 in 5 minutes,
- Newborns who have undergone any surgery
- Newborns with birth trauma (especially rapid births)
- There are situations that may prevent communication with parents (e.g. language problems).
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- Newborns planned to be transferred to another hospital
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Turkey (Türkiye) · 1 center
- Bartın University — Bartın
Identifiers
NCT: NCT06567093 · 2024-SBB-0076